Manager, Local Pharmacovigilance

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Establish and oversee the local pharmacovigilance system, ensuring effective management of local PV activities.

• Conduct comprehensive local literature reviews.

• Gather and manage local individual case safety reports (ICSRs).

• Execute PV intelligence screening.

• Maintain the local Pharmacovigilance System Master File (PSMF) where applicable.

• Organize local data collection efforts.

• Administer local pharmacovigilance agreements (PVAs).

• Modify and submit local Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) as needed.

• Conduct local signal detection when applicable.

• Implement further risk minimization strategies.

• Review documents related to local post-authorization safety studies.

• Engage in PV-related audits and inspections.

• Participate in regular project meetings.

• Provide monthly updates on the status of the local pharmacovigilance system.

• Ensure that affiliate employees, service providers, and third parties receive appropriate PV training.

• Collaborate with the client’s global pharmacovigilance system and relevant global and local departments.

• Develop, review, and maintain pharmacovigilance procedures pertinent to local responsibilities.

• Work alongside the Deputy and share pertinent information regarding current PV activities.

• Identify and escalate Medical Information requests within designated timelines.

• Maintain 24/7 availability for the Competent Authority concerning pharmacovigilance-related issues.

• Act as the official point of contact with the Competent Authority.

• Oversee the local pharmacovigilance system to ensure compliance with national regulations and laws.

• Promptly inform the health authority of significant safety issues, product recalls, or changes to the benefit-risk profile.

• Coordinate the dissemination of national safety communications.

• Ensure updates and validations of the local pharmacovigilance system.

• Serve as the internal contact for the EU Qualified Person for Pharmacovigilance (EU-QPPV) and the global PV team.

• Assume the role of Deputy in the event of planned or unplanned absence.

⛳️ Requirements

• A Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience is necessary.

• A minimum of 2 years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a similar area is required.

• Certification in regulatory affairs, quality management, compliance, or auditing is preferred.

• Proficiency in business-fluent English.

• Skills in Hungarian and Polish languages are advantageous.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Opportunities for professional development and training.

• Comprehensive health and wellness programs.

• Flexible working arrangements.

• Supportive and collaborative work environment.